Wednesday, April 23, 2008

Congress Blasts the FDA for being Incompetent

(AP) House members chastised the Food and Drug Administration on Tuesday for not doing more inspections of foreign drug manufacturers in the wake of a litany of problems with the blood thinner heparin and other products.

"Last year, this nation's regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people," said Rep. Bart Stupak, D-Mich. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us."

FDA Commissioner Andrew von Eschenbach told a House subcommittee that he has asked the administration for more money to conduct inspections, but he did not specify how much. He agreed that more inspections are needed, but not to the lengths Democrats suggested, which is to inspect every foreign firm every two to three years.

"I don't believe that's the solution to the problem," von Eschenbach said. "It's much more complex, and the solution needs to be much more comprehensive than simply inspecting a facility."

Typical spin from a Bush loyalist--regularly checking out firms is costly, time-consuming and makes everyone pull nervously at their collar, but it's virtually the only way to ensure compliance with the law. What do you get when you "trust" the industry or industries to "self-regulate?" You get cost-cutting, corner-cutting, and dead people.

Spare me that "government is the problem" and that "libertarian" bullshit on this one--the only thing that is going to ensure that we even approach having a safe supply of materials is to have a hard-assed inspector with a clipboard and an eye for detail looking into what these firms are up to.

Republican members of the subcommittee were in agreement with Democrats that the lack of foreign inspections is a big problem.

"We have already heard the numbers that show the imbalance in risk priorities, with most domestic firms inspected about every two years, but literally hundreds of foreign firms that have not seen an inspection, if at all, in a decade," said Rep. John Shimkus, R-Ill. "Clearly these priorities need to be brought closer into balance."

The Government Accountability Office testified Tuesday that the FDA was making progress in conducting more inspections of foreign drug manufacturers, but still inspects relatively few facilities.

The agency conducted 30 such inspections in the last fiscal year and plans to conduct at least 50 this year, according to government auditors.

That's not nearly enough for members of Congress, who point out that there are more than 3,200 foreign drug firms listed by the FDA.

Of course the Republicans agreed--they're not THAT batshit crazy. See, it's not about ideology. It's not about letting the market decide or the individual do for themselves. It's about a safe supply of fucking drugs that actually work. So, out of 3,200 firms, we're inspecting 80 over a two year period? How the hell is that supposed to keep the American people safe? How hard is it to actually do the job? You'd think there wasn't a Bush appointee alive who was even remotely capable of showing up for work.

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